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United States · US · US:0597-0075_94768574-0d3e-46f0-9f75-ab3c9f52857d
Spiriva
Orange BookUNIISPLATC R03BB04
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerBoehringer Ingelheim Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeR03BB04
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc1105970075413 BLISTER PACK in 1 CARTON (0597-0075-41) / 10 CAPSULE in 1 BLISTER PACK
- ndc1105970075479 BLISTER PACK in 1 CARTON (0597-0075-47) / 10 CAPSULE in 1 BLISTER PACK
- ndc1105970075751 BLISTER PACK in 1 CARTON (0597-0075-75) / 5 CAPSULE in 1 BLISTER PACK
Annotations
UNII (FDA Substance ID)
L64SXO195N
TIOTROPIUM BROMIDE MONOHYDRATE
RxCUI 1298831
Orange Book
N021395
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "L64SXO195N",
"rxcui": "1298831",
"inchikey": "MQLXPRBEAHBZTK-SEINRUQRSA-M",
"display_name": "TIOTROPIUM BROMIDE MONOHYDRATE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL; RESPIRATORY (INHALATION)",
"spl_meta": {
"7b656b14-fcaa-2741-f6f0-e0be48971c02": {
"match": "brand_token",
"title": "SPIRIVA RESPIMAT (TIOTROPIUM BROMIDE INHALATION SPRAY) SPRAY, METERED [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.]",
"spl_version": "14",
"published_date": "2025-12-04"
}
},
"productid": "0597-0075_94768574-0d3e-46f0-9f75-ab3c9f52857d",
"productndc": "0597-0075",
"dosage_form": "CAPSULE",
"orange_book": {
"appl_no": "021395",
"products": [
{
"rs": true,
"rld": true,
"te_code": "AB",
"strength": "EQ 0.018MG BASE/INH",
"product_no": "001",
"approval_date": "Jan 30, 2004"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "TIOTROPIUM BROMIDE MONOHYDRATE",
"proprietary_name": "Spiriva",
"active_ingred_unit": "ug/1",
"application_number": "NDA021395",
"marketing_category": "NDA",
"nonproprietary_name": "TIOTROPIUM BROMIDE",
"start_marketing_date": "20051011",
"active_numerator_strength": "18"
}Related drugs
Other records sharing ATC code R03BB04.
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